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Prospective, Randomized Phase II Clinical Trial to Select Primary Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer Stage FIGO IIIC and IV


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Neoplasms

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Trial Information

Prospective, Randomized Phase II Clinical Trial to Select Primary Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer Stage FIGO IIIC and IV


Inclusion Criteria:



- histological confirmed ovarian neoplasm

- Figo stage IIIC (2cm extrapelvic disease) or Figo IV

- more than 500 ml ascites volume (measured by sonography)

- age > 18 years old

- ECOG <= 2

- adequate hepatological, renal and haematological function

- informed consent

Exclusion Criteria:

- concomitant or previous malignant diseases

- debulking procedures on initial surgical approach

- existing peripheral sensoric neuropathy >= grade 2

- acute infections

- mental disorders, cerebral metastasis

- bowel obstruction

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Preoperative reduction of ascites volume

Outcome Time Frame:

preoperative: after 2nd or 3rd cycle of chemotherapy (3-weekly course)

Principal Investigator

Walther C Kuhn, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bonn

Authority:

Germany: Ethics Commission

Study ID:

PRIMOVAR-1

NCT ID:

NCT00551577

Start Date:

March 2003

Completion Date:

January 2008

Related Keywords:

  • Ovarian Neoplasms
  • Ovarian neoplasms,
  • Neoadjuvant Therapy,
  • Docetaxel,
  • Neoplasm, Residual
  • Neoplasms
  • Ovarian Neoplasms

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